Alli Side Effects

Generic Name: orlistat

Note: This page contains information about the side effects of orlistat. Some of the dosage forms included on this document may not apply to the brand name Alli.

Not all side effects for Alli may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to orlistat: oral capsule

In addition to its needed effects, some unwanted effects may be caused by orlistat (the active ingredient contained in Alli). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking orlistat:

More common
  • Bladder pain
  • body aches
  • chills
  • cough
  • diarrhea
  • difficulty with breathing
  • ear congestion
  • fever
  • general feeling of discomfort or illness
  • headache
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • muscle aches and pains
  • nasal congestion
  • nausea
  • runny nose
  • shivering
  • sneezing
  • sore throat
  • sweating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
Less common
  • Tightness in the chest
  • tooth or gum problems
  • troubled breathing
  • wheezing
Rare
  • Bloody or cloudy urine
  • change in hearing
  • contagious diarrhea
  • dark urine
  • difficult or painful urination
  • earache
  • fast heartbeat
  • frequent urge to urinate
  • general tiredness and weakness
  • hives
  • hoarseness
  • irritation
  • itching
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • noisy breathing
  • pain in the ears
  • rash
  • redness of the skin
  • shortness of breath
  • skin blisters
  • swelling of the eyelids, face, lips, hands, or feet
  • troubled swallowing
  • upper right abdominal or stomach pain
  • yellow eyes and skin
Incidence not known
  • Anxiety
  • bloating
  • blurred vision
  • cold sweats
  • coma
  • confusion
  • constipation
  • cool, pale skin
  • depression
  • dizziness
  • dry skin and hair
  • feeling cold
  • hair loss
  • hoarseness or husky voice
  • increased hunger
  • indigestion
  • loss of appetite
  • muscle cramps and stiffness
  • nervousness
  • nightmares
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • seizures
  • weight gain

Some of the side effects that can occur with orlistat may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abdominal or stomach pain or discomfort
  • back pain
  • difficulty with moving
  • gas with leaky bowel movements
  • inability to hold bowel movement
  • increases in bowel movements
  • loss of bowel control
  • oily bowel movements
  • oily spotting of underclothes
Less common
  • Itching of the vagina or genital area
  • menstrual changes
  • pain during sexual intercourse
  • rectal pain or discomfort
  • thick, white vaginal discharge with no odor or with a mild odor

For Healthcare Professionals

Applies to orlistat: oral capsule

General

In general, the adverse effects of orlistat (the active ingredient contained in Alli) are mild and transient. Because the drug is not systemically absorbed, most adverse effects are limited to the gastrointestinal tract and are primarily extensions of the pharmacologic activity of the drug.

Gastrointestinal

During clinical trials, approximately half of all incidents of GI adverse events associated with orlistat (the active ingredient contained in Alli) treatment lasted less than one week, and a majority lasted for no more than four weeks. However, these side effects may occur in some persons over a period of 6 months or longer.

A 42-year-old female experienced constipation, polyuria, polydipsia, and increased lower-leg edema after 2 weeks of treatment with orlistat 120 mg 3 times daily. After the drug was discontinued for 4 days, the symptoms resolved. On reinstitution of the orlistat therapy, the symptoms reappeared within 2 days. Thereafter, the drug was permanently discontinued.

Gastrointestinal (GI) side effects including oily spotting, flatus with discharge, fecal urgency, fatty or oily stool, oily evacuation, increased defecation, and fecal incontinence have been reported in greater than or equal to 5% of patients. Cholelithiasis has been reported in 2.9% of patients versus 1.8% in placebo. Other GI side effects possibly related to orlistat treatment have included abdominal pain and discomfort, nausea, infectious diarrhea, rectal pain and discomfort, tooth disorder, gingival disorder, and vomiting. At least one case of constipation has been reported. Pancreatitis has also been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have rarely included pruritus, rash, urticaria, angioedema, bronchospasm, and anaphylaxis. At least one case of cutaneous leukocytoclastic vasculitis has also been reported.

A 34-year-old male with a history of obesity experienced cutaneous leukocytoclastic vasculitis coincident with orlistat therapy. He decided to take orlistat (120 mg before meals) as medical therapy for obesity. Seventy-two hours after the onset of this treatment, he experienced myalgias and arthralgias. He also observed the presence of maculopapular lesions in rapidly increasing numbers in his lower extremities. A skin biopsy revealed leukocytoclastic vasculitis affecting capillaries and venules. Orlistat was discontinued and bed rest and nonsteroidal anti-inflammatory drugs were prescribed. Following initiation of this procedure, a rapid improvement of the cutaneous lesions was attained.

Respiratory

Respiratory side effects have included influenza, upper respiratory infection, lower respiratory infection, and ear, nose and throat symptoms.

Musculoskeletal

Musculoskeletal side effects have included back pain, pain in the lower extremities, arthritis, myalgia, joint disorder, and tendonitis.

Nervous system

Nervous system side effects have included headache and dizziness. Postmarketing side effects have included reports of convulsions in patients treated concomitantly with orlistat (the active ingredient contained in Alli) and antiepileptic drugs.

Dermatologic

Dermatologic side effects have included rash and dry skin. Rare cases of bullous eruptions have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included menstrual irregularities and vaginitis. Urinary tract infection has also been reported.

Psychiatric

Psychiatric side effects have included psychiatric anxiety and depression.

Cardiovascular

Cardiovascular side effects have included pedal edema. At least one case of hypertension has also been reported.

A 40-year-old previously healthy female experienced hypertension coincident with orlistat therapy. She took sporadic doses for some months and then increased the dosage to 120 mg three times a day. She experienced dizziness, peripheral edema, and pulsating headache and discontinued treatment. On medical examination, her blood pressure was 190/100 mm Hg on three different measurements. She was advised to discontinue orlistat, and a few days later her blood pressure had decreased to 160/90 mm Hg and the edema had regressed.

Hematologic

Hematologic side effects have included decreased prothrombin, increased INR, and unbalanced anticoagulant treatment with changes of hemostatic parameters in patients treated concomitantly with orlistat (the active ingredient contained in Alli) and anticoagulants.

Metabolic

Metabolic side effects have included hypoglycemia in clinical trials of obese diabetic patients. At least one case of diabetic ketoacidosis has also been reported, in addition to a case of polyuria and polydipsia.

An 18-year-old female with type 1 diabetes for the past 3 years experienced diabetic ketoacidosis coincident with orlistat therapy. She presented to the hospital after she began taking, on her own, orlistat 120 mg three times per day in addition to a low-calorie diet. Laboratory data showed severe ketosis and positive urinary ketones. Orlistat was discontinued, and she was started on intravenous hydration and insulin. She showed significant improvement over a period of 5 days.

A 42-year-old female experienced constipation, polyuria, polydipsia, and increased lower-leg edema after 2 weeks of treatment with orlistat 120 mg 3 times daily. After the drug was discontinued for 4 days, the symptoms resolved. On reinstitution of the orlistat therapy, the symptoms reappeared within 2 days. Thereafter, the drug was permanently discontinued.

Hepatic

Hepatic side effects have included rare reports of an increase in transaminases and in alkaline phosphatase, and exceptional cases of hepatitis. No causal relationship or physiopathological mechanism between hepatitis and orlistat (the active ingredient contained in Alli) therapy has been established. At least one case of severe hepatic injury has also been reported. Hepatic side effects submitted post-marketing to the FDA's Adverse Event Reporting System have included jaundice, weakness, and abdominal pain. The FDA has not established an association between liver injury and orlistat at this time.

A 15-year-old female without a remarkable medical history experienced severe hepatic injury coincident with orlistat therapy. She had taken orlistat 120 mg three times daily for 7 days for obesity. One week later, she was admitted to an emergency hospital with abdominal pain, malaise, nausea, and diarrhea. Her serum aspartate aminotransferase and alanine aminotransferase levels were surprisingly high at 8269 intl units/L and 9976 intl units/L, respectively. She was given vitamin K intravenously for 5 days, and liver function tests results normalized within 1 month.

Renal

Renal side effects including at least one case of acute oxalate nephropathy have been reported.

A 57-year-old female with underlying chronic kidney disease experienced acute kidney injury secondary to acute oxalate nephropathy coincident with orlistat therapy. Acute kidney injury was associated temporally with an increased dosage of orlistat therapy and the development of increased fat malabsorption. Kidney biopsy indicated deposition of calcium oxalate crystals within tubular lumens, consistent with acute oxalate crystals within tubules. A steady improvement in renal function was subsequently observed. Results of a repeated 24-hour urine oxalate collection performed 3 weeks later when kidney function had improved were within normal parameters.

Other

Other side effects have included fatigue, otitis, and sleep disorders.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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